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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDjo Global
9800 Metric Blvd.
Austin, TX 78758
PMA NumberP050050
Supplement NumberS005
Date Received11/13/2012
Decision Date01/24/2013
Product Code NTG 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.
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